Recall Z-0808-2011 ยท FTL Mesh, Surgical, Polymeric
American Medical Systems, Inc.
Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
| Date | Dec 27, 2010 (initiated Sep 7, 2010) |
| Status | Terminated |
| Reason | American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture. |
| Root cause | Package design/selection |
| Action | Consignees were sent an AMS "Urgent Product Recall" letter dated September 7, 2010. The letter described the problem and the product involved. They requested consignees to return any existing stock product and to return the Product Recall Acknowledgement form enclosed. Customers may request a credit or a full refund or also, arrange for replenishment of AdVance product. Questions regarding the recall should be directed towards AMS Customer Service at 1-800-328-3881. |
| Quantity | 7,069 |
| Distribution | Worldwide Distribution -- All states in the Continental USA including DC and Puerto Rico and countries of ARGENTINA, AUSTRIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, GERMANY, ESTONIA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, CROATIA, IRE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM American Medical Systems, Inc., Feb 3, 2006 |